Clinical Trial: Use of a Rapid Turnaround Test for NG/CT to Improve Treatment of Women Presenting With Possible STIs

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Use of a Rapid Turnaround Test for Gonorrhea & Chlamydia to Improve Treatment of Women Presenting With Possible Sexually Transmitted Infections

Brief Summary: The purpose of this study is to evaluate the effect of utilizing a rapid turnaround CT/NG test on treatment of female patients in the emergency department or urgent care setting with possible STIs.

Detailed Summary: All females ages 18-55 presenting to the UMMC Emergency Department or Urgent Care whose provider suspects sexually transmitted infection will be offered study enrollment and be randomly assigned to either the control or the experimental group. Both groups will have a urinalysis, a pregnancy test, a pelvic exam, and an endocervical sample collected, but the experimental group's urine will be used to run the rapid turnaround test (RTAT) instead of the standard PCR. Data will be collected regarding provider decision making, length of stay in the emergency department, patient satisfaction, clinician satisfaction, further healthcare sought by patient, and cost surrounding each treatment.
Sponsor: University of Maryland

Current Primary Outcome: Rate of Overtreatment with Antibiotics [ Time Frame: One year ]

Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of Stay [ Time Frame: One year ]
    Evaluate the effect of utilizing a rapid turnaround CT/NG test on length of stay in the Emergency Department.
  • Test congruence [ Time Frame: One year ]
    Compare the congruence of test results between the rapid turnaround CT/NG test with the usual care test (send out PCR) in those subjects that have both performed (Experimental Group).
  • Healthcare costs. [ Time Frame: One year ]
    Evaluate the effect of utilizing a rapid PCR test on healthcare costs.
  • Patient and provider satisfaction [ Time Frame: One year ]
    Evaluate patient and provider satisfaction with the 2 diagnostic groups.
  • Need for additional healthcare [ Time Frame: One year ]
    Compare need for additional healthcare utilization between the groups.


Original Secondary Outcome: Same as current

Information By: University of Maryland

Dates:
Date Received: March 27, 2017
Date Started: May 15, 2017
Date Completion: May 2018
Last Updated: March 27, 2017
Last Verified: March 2017